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Proactive Outreach for Smokers in VA Mental Health (PROMH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01737281
First received: November 27, 2012
Last updated: August 19, 2014
Last verified: August 2014

November 27, 2012
August 19, 2014
July 2014
June 2016   (final data collection date for primary outcome measure)
Abstinence from smoking [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01737281 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Proactive Outreach for Smokers in VA Mental Health
Proactive Outreach for Smokers in VA Mental Health

Veterans with a mental health diagnosis have higher a prevalence of smoking and higher rates of smoking-related morbidities compared to the general Veteran population. Smoking cessation treatment delivery in the VA typically depends on a visit from a health care provider. In this study, investigators will use information within the electronic medical record to identify all smokers with a mental health diagnosis at a VA health care facility and proactively reach out to enroll them in an intensive tobacco cessation treatment program. This approach could be generalized to other behaviors and provides a novel method to improve the health of an entire population of patients.

Background:

Tobacco use is the leading preventable cause of death in the United States and contributes up to 24% of all VA healthcare costs. Veterans enrolled in the VA healthcare system smoke substantially more than the general population, which is particularly true among Veterans diagnosed with mental illness. Patients with bipolar disorder or schizophrenia have the highest smoking rates (69% and 58-90%, respectively) followed by those with PTSD (45-63%) and depression (31-51%). Numerous barriers exist for tobacco cessation among mental health patients, including high nicotine dependency, low rates of follow through for referrals, and limited availability of tobacco treatment tailored to their needs.

Rationale:

Most medical care providers assess tobacco use and advise smokers to quit, but they have insufficient time to follow up with treatment, leading to low long-term quit rates. Mental health providers who often meet regularly with patients report that they find tobacco cessation outside the scope of their practice and neither assess tobacco use nor refer smokers for treatment. These practice patterns have been very difficult to change even with intensive methods and across various settings and provider types. Therefore, the investigators here propose to use the electronic medical record system to identify smokers receiving mental health care and proactively reach out to engage them in treatment in line with the following aims:

Specific Aims:

  1. Compare the reach and efficacy of a proactive outreach telephone-based tobacco cessation (PRO) program for patients seen in mental health to usual care (UC) advice and referral to local VA and community tobacco cessation resources.
  2. Model longitudinal associations between baseline sociodemographic, medical and mental health characteristics and abstinence at 6 and 12 months in the PRO and UC conditions.

Methods:

Investigators will use the electronic medical record to identify N=6,400 patients across 4 VA healthcare facilities who have a clinical reminder code indicating current tobacco use in the past year and who have had a mental health visit in the past 6 months. Investigators will send each patient an introductory letter and baseline survey. Respondents will be randomized in a 1:1 fashion to intervention or control. Control participants will receive VA usual care. Intervention participants will receive proactive telephone counseling and cessation medications. Investigators will assess tobacco use at 6 and 12 months from enrollment. The primary outcome is cotinine-validated abstinence at the 12-month follow-up.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Smoking
  • Behavioral: Proactive outreach
    Proactive contact (mail and phone) offering smoking cessation medications and telephone counseling.
  • Behavioral: Usual care
    Usual smoking cessation care from VA clinical staff.
  • Experimental: Proactive outreach
    Proactive outreach to deliver 7 sessions of telephone counseling and nicotine replacement therapy.
    Intervention: Behavioral: Proactive outreach
  • Active Comparator: Usual care
    Usual smoking cessation care from clinical staff
    Intervention: Behavioral: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6400
September 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Current smoker (i.e., any tobacco use in past 30 days)
  • Seen in VA Mental Health Clinic in prior 12 months

Exclusion Criteria:

  • Dementia
  • Does not speak English
  • Does not have a telephone and mailing address (necessary to mail out consent materials and to deliver the telephone-based intervention)
Both
18 Years and older
Yes
Contact: Erin S Rogers, MPH (212) 686-7500 ext 7358 erin.rogers2@va.gov
Contact: Scott E Sherman, MD MPH (212) 686-7500 ext 7386 Scott.Sherman@va.gov
United States
 
NCT01737281
IIR 11-291, 1I01HX000817-01A2
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Scott E Sherman, MD MPH New York, NY
Department of Veterans Affairs
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP